Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NICCO CRCI
Study information
Scientific title
A randomised trial of adjuvant 5-fluorouracil, leucovorin and radiotherapy in colorectal adenocarcinoma
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Colon, Rectal cancer
Intervention
COLON CANCER: Following surgery patients are randomised to one of two groups:
1. Group A: No adjuvant therapy
2. Group B: Adjuvant chemotherapy with 5-fluorouracil and folinic acid repeated every 14 days for eight courses.
RECTAL CANCER: Following surgery patients are randomised to one of two groups:
1. Group A: No adjuvant therapy
2. Group B: Radiotherapy 4400 cGy in 22 daily fractions plus adjuvant chemotherapy with 5-fluorouracil and folinic acid repeated every 14 days for eight courses. Radiotherapy to be given five days per week prior to or concurrent with chemotherapy.
Intervention type
Drug
Phase
Not Specified
Drug names
5-fluorouracil and folinic acid (leucovorin)
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2002
Overall trial end date
01/08/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 to 80 years
2. World Health Organisation (WHO) performance status zero to two
3. Histological proof of colorectal adenocarcinoma
4. The entire colorectum must be visualised pre- or postoperatively to exclude synchronous carcinoma
5. Potentially curative surgery
6. Adjuvant treatment to be initiated within six weeks of surgery
7. Adequate bone marrow, renal and hepatic function
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
No previous malignancy except carcinoma in situ of cervix or basal cell carcinoma of skin
Recruitment start date
01/08/2002
Recruitment end date
01/08/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Wyeth-Lederle Ltd (UK)
Sponsor details
Huntercombe Lane South
Taplow
Maidenhead
Berkshire
SL6 0PH
United Kingdom
-
info@isrctn.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Wyeth-Lederle Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Friends Of Montgomery House (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary